Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus

April 15, 2010 updated by: Astellas Pharma Inc

A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen

Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving a primary partial liver graft from a living donor
  • Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study

Exclusion Criteria:

  • Patients receiving a multi-organ transplantation or having previously received an organ transplantation
  • Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
  • Patients allergic or intolerant to macrolide antibodies or Tacrolimus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. FK506E high dose group
Drug: FK506E (modified release tacrolimus)
oral
Other Names:
  • MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
injection
Other Names:
  • FK506
  • tacrolimus
Experimental: 2. FK506E low dose group
Drug: FK506E (modified release tacrolimus)
oral
Other Names:
  • MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
injection
Other Names:
  • FK506
  • tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of pharmacokinetic parameters
Time Frame: Day 6 and Day 14
Day 6 and Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute rejection
Time Frame: within 12 weeks
within 12 weeks
Time to acute rejection
Time Frame: within 12 weeks
within 12 weeks
Assessment of graft survival
Time Frame: within 12 weeks
within 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Korea, Inc.

Investigators

  • Study Chair: Use Central Contact, Astellas Pharma Korea, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 27, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 16, 2010

Last Update Submitted That Met QC Criteria

April 15, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-08-04-KOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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